Pharmacovigilance Specialist – Local PV System Management

About the role

Johnson & Johnson is seeking a dedicated Pharmacovigilance Specialist to ensure the local PV system complies with regulations and company policies. You will act as an ambassador for the Medical Safety mission, supporting both regional and global initiatives.

Key responsibilities

• Manage the collection, review, reporting, reconciliation, and follow‑up of Individual Case Safety Reports (ICSRs).
• Oversee local literature processes and vendor activities related to PV.
• Maintain audit and inspection readiness, monitor inbound/outbound ICSR compliance, and support corrective actions.
• Prepare, translate (if needed), submit, and track aggregate safety reports in line with local regulatory requirements.
• Participate in or lead local, regional, and global LMS projects and initiatives.

Required profile

• Strong understanding of pharmacovigilance regulations and company safety policies.
• Experience with ICSR management and aggregate safety reporting.
• Ability to work collaboratively with Medical Safety Quality, Regulatory Affairs, and external vendors.
• Proactive attitude toward compliance, audit readiness, and continuous improvement.

Required skills

• Pharmacovigilance processes and ICSR lifecycle management.
• Regulatory reporting and aggregate safety report preparation.
• Vendor oversight and audit/inspection readiness.

What we offer

• Opportunity to work within a global healthcare leader.
• Inclusive work environment that values diversity and individual merit.
• Access to professional development and cross‑functional projects.